Avoiding Medical Device Clinical Evaluation Pitfalls
Angela Siebeneck, MSN RN |Director of Regulatory Strategy and Policy, Certara
The clinical evaluation process for medical devices has expanded from a simple process to a comprehensive justification and critical appraisal of its safety and performance. This session will review clinical evaluation requirements and discuss strategies to help you avoid questions from notified bodies- organizations in charge of the conformity assessment of medical devices before they are placed on the market or put into service.